The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
211
UBT251 Injection and UBT251 Injection Placebo once weekly
UBT251 Injection and UBT251 Injection Placebo once weekly
UBT251 Injection and UBT251 Injection Placebo once weekly
The United Bio-Technology (Hengqin) Co., Ltd.
Zhuhai, Guangdong, China
Change From Baseline in HbA1c at Week 24
HbA1c was obtained at baseline and at Week 24
Time frame: Baseline to week 24
Change Change from baseline to week 12, 16, 20 in HbA1c
HbA1c was obtained at baseline and at Week 12, 16, 20
Time frame: Week 12, 16, 20
Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24
FPG was obtained at baseline and at Week 12, 16, 20, 24
Time frame: Week 12, 16, 20, 24
Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24
2-hour post-standard-meal plasma glucose was obtained at baseline and at Week 12, 24
Time frame: Week 12, 24
Change in body weight from baseline to week 12, 24
Body Weight was obtained at baseline and at Week 12, 24
Time frame: Week 12, 24
Change in waist circumference from baseline to week 12, 24
Waist circumference was obtained at baseline and at Week 12, 24
Time frame: Week 12, 24
HbA1c target achievement rates (<7.0%) at Week 24
Percentage of participants who achieved HbA1c \<7.0% is presented
Time frame: Week 24
HbA1c target achievement rates (≤6.5%) at Week 24
Percentage of participants who achieved HbA1c ≤6.5% is presented
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UBT251 Injection and UBT251 Injection Placebo once weekly
Semaglutide Injection (Ozempic®) once weekly
Time frame: Week 24
FPG target achievement rate (4.4-7.0 mmol/L) at Week 24
Percentage of FPG target achievement (4.4-7.0 mmol/L) at Week 24
Time frame: Week 24
Combined target achievement rate for both HbA1c and FPG at Week 24
Percentage of Combined target achievement rate for both HbA1c and FPG at Week 24
Time frame: Week 24
Change from baseline to week 24 in fasting lipid profile
Fasting lipid profile was obtained at baseline and at Week 24
Time frame: Week 24
Change from baseline to week 24 in systolic blood pressure
Systolic blood pressure was obtained at baseline and at Week 24
Time frame: Week 24
Change from baseline to week 24 in diastolic blood pressure
Diastolic blood pressure was obtained at baseline and at Week 24
Time frame: Week 24